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MIG-HD: Multicentric Intracerebral Grafting in Huntington's Disease (MIG-HD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00190450
First Posted: September 19, 2005
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
The aim of this study is to assess the clinical benefit of intrastriatal grafting of human cells from the foetal ganglionic eminence in patients with Huntington's disease. The duration of the study will be 52 months. A first group of patients will be grafted at M13-14 (early G group) and a second group of patients will be grafted at M33-34 (late G group). The principal criterion is the comparison of the progression between M12 and M32 of the motor score (TMS) of the UHDRS between grafted patients (early G group) and not yet grafted patients (late G group). An additional evaluation will be performed to compare the progression in individual patients over the 52-month study period. We will thus be able to compare the pre and post-graft TMS progression for all patients.

Condition Intervention Phase
Huntington Disease Biological: graft intracerebral of foetal neurons Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric Intracerebral Grafting in Huntington's Disease

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Motor UHDRS rating scale, at randomization, 20 month after transplant [ Time Frame: during de study ]

Secondary Outcome Measures:
  • Neurologic, Cognitive, Neurophysiologic, Psychiatric, MRI and Pet-scan evaluation at randomization, 20 month after and at the end of the protocol [ Time Frame: during the study ]

Enrollment: 54
Study Start Date: January 2002
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Early Graft (Early G)
Biological: graft intracerebral of foetal neurons
graft intracerebral of foetal neurons
Experimental: 2
Late Graft (Late G)
Biological: graft intracerebral of foetal neurons
graft intracerebral of foetal neurons

Detailed Description:

The aim of this study is to show the existence of a clinical benefit rising from a substitution of the striatal neurons degenerated among a large cohort of Huntington's patient at early stage by homologous neurons coming from human foetuses, This effect will be estimated, compared with a group of patients not treated at first, on the results of the motor scale of the Unified Huntington Disease Rating Scale (UHDRS, Huntington study group, on 1996).

Transplants will be realized in two surgical times to avoid the risk of hurts per-operating, BI-CAUDES, if transplants were realized at single time. The minimal interval between both transplants will be of 2 weeks, so as to let the patient recover of the first general anaesthesia It's a multicentric study of phase II randomised and controlled, with direct individual benefit.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Disease clinically declared since at least 1 year ,UHDRS motor > or =5
  • TFC > or = 10.
  • CAG > or = 36
  • Age between 18 and 65
  • Family and socially integrated subject
  • Informed consent.

Exclusion Criteria:

  • Severe intellectual deterioration or neuropsychiatric disorders making the follow-up longitudinal too complicated (score MATTIS < 120).
  • Not-observance of the appointments and the symptomatic treatments in pre-surgical period.
  • Intercurrent disease making a surgical operation impossible.
  • Associated disease having a neurological repercussion, intercurrent cerebral lesion with the IRM.
  • Visceral affection engraves, evolutionary, which brings into play the vital forecast or makes risks for general anaesthesia.
  • Mental Affection likely to disturb adhesion with the protocol, and in particular antecedents of hallucinations spontaneous and/or induced by the drugs; antecedents of serious depression having required repeated hospitalizations; antecedents of repeated suicide attempts.
  • Cerebral morphological anomalies, others that those characteristic of the disease, noted with the IRM or the tomodensitometry.
  • Participation in progress, or stopped since less than three months, with a therapeutic protocol of the Huntington's disease Exclusion Criteria (pre-randomization)
  • TFC < 8
  • Not-observance of the appointments and the symptomatic treatments in pre-surgical period.
  • Intercurrent disease returning the surgery or impossible immunosuppression. v Subject completely isolated with his family and socially..
  • UHDRS motor < 5.
  • Positives serologies for HIV1, HIV2, AgP24, HTLV1 et 2, HEPATITE B, HEPATITE C, syphilis
  • Psychiatric disorders being able to compromise the follow-up.
  • Signs other than Huntington with the IRM.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190450


Locations
France
Hopital Henri Mondor
Paris, Ile de France, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: A-C. BACHOUD-LEVI, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190450     History of Changes
Other Study ID Numbers: P 001106
First Submitted: September 15, 2005
First Posted: September 19, 2005
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Huntington
graft
cellular therapy
striatum

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders